Back to resultsA Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Copegus (ribavirin)
Copegus (ribavirin)
peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a [Pegasys]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
- adult patients >/= 18 years of age
- serologic evidence of chronic hepatitis C infection
- compensated liver disease
- negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment
Exclusion Criteria:
- history or other evidence of a medical condition associated with chronic liver disease other than HCV
- hepatitis A, hepatitis B or HIV infection
- hepatocellular carcinoma
- severe concomitant disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
safety and tolerability with regard to clinical AEs and laboratory parameters
Secondary Outcome Measures
safety with regard to hematological parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00940420
Brief Title
A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
Official Title
Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2695 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Copegus (ribavirin)
Intervention Description
800 - 1200 mg po daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Copegus (ribavirin)
Intervention Description
800 - 1200 mg po daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc once weekly for 24 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc once weekly for 48 weeks
Primary Outcome Measure Information:
Title
safety and tolerability with regard to clinical AEs and laboratory parameters
Time Frame
assessed every 2 weeks throughout study and after 8 weeks follow-up
Secondary Outcome Measure Information:
Title
safety with regard to hematological parameters
Time Frame
assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients >/= 18 years of age
serologic evidence of chronic hepatitis C infection
compensated liver disease
negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment
Exclusion Criteria:
history or other evidence of a medical condition associated with chronic liver disease other than HCV
hepatitis A, hepatitis B or HIV infection
hepatocellular carcinoma
severe concomitant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Afula
ZIP/Postal Code
18101
Country
Israel
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
City
Bat Yam
Country
Israel
City
Beer Sheva
ZIP/Postal Code
84105
Country
Israel
City
Hadera
ZIP/Postal Code
38100
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Haifa
ZIP/Postal Code
33394
Country
Israel
City
Haifa
ZIP/Postal Code
34362
Country
Israel
City
Holon
ZIP/Postal Code
58100
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
City
Nazareth
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Petach Tikva
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Safed
ZIP/Postal Code
13110
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Zerifin
ZIP/Postal Code
6093000
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
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